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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: domperidone
Date Designated: 09/02/2011
Orphan Designation: Treatment of hypoprolactinemia in breastfeeding mothers, and in some hypoprolactinemic conditions following the use of cabergoline or bromocriptine in mothers who wish to initiate or return to breastfeeding
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Texas Tech University Health Sciences Center
1400 S Coulter St.
Amarillo, Texas 79106
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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